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Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision (REACT)

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Abbott

Status

Completed

Conditions

The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device

Treatments

Device: Implantation of an ICD/CRT-D device
Device: Merlin.NET PCN

Study type

Interventional

Funder types

Industry

Identifiers

NCT01090349
CR-09-064-WW-RC

Details and patient eligibility

About

St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.

This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
  • The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
  • The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
  • The patient is mentally capable to participate in the investigation (based on the physician's discretion).
  • The patient is 18 years of age or older

Exclusion criteria

  • The patient is being actively considered for cardiac transplantation.
  • The patient has primary valvular disease that has not been corrected.
  • The patient had a myocardial infarction within the last month
  • The patient had unstable angina within the last month.
  • The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
  • The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
  • The patient is pregnant.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

220 participants in 2 patient groups

Direct Alerts ON
Experimental group
Description:
Direct Alerts in implantable device were turned on
Treatment:
Device: Merlin.NET PCN
Device: Implantation of an ICD/CRT-D device
Direct Alerts OFF
Active Comparator group
Description:
Direct Alerts in implantable device were turned off
Treatment:
Device: Merlin.NET PCN
Device: Implantation of an ICD/CRT-D device

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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